Human Factors and Medical Devices

Human factors/usability engineering focuses on the interactions between people and devices. Figure 1 presents a model of the interactions between a user and a device, the processes performed by each, and the user interface between them. The critical element in these interactions is the device user interface, depicted as the red zone.

To understand the user-device system, it's important to understand the ways that people:

Perceive information from the device,

Interpret the information and make decisions about what to do, and

Manipulate the device, its components, and/or its controls. (e.g., modify a setting, replace a component, or stop the device).

It's also important to understand the ways that devices:

Receives input from the user, and then

Responds and provides feedback to the user about the effects of their actions.

Human factors/usability engineering is used to design the user-device interface. The user interface includes all components with which users interact while preparing the device for use (e.g., unpacking, set up, calibration), using the device, or performing maintenance (e.g., cleaning, replacing a battery, making repairs).

Why is Human Factor Engineering important to medical devices?

For medical devices, the most important goal of the human factors/usability engineering process is to minimize use-related hazards and risks and then confirm that these efforts were successful and users can use the device safely and effectively.